TDA-2018年度新药评审报告(英文版).pdf

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CENTER FOR DRUG EVALUATION AND RESEARCH ADVANCING HEALTH THROUGH INNOVATION 2018 NEW DRUG THERAPY APPROVALS Impact | Innovation | Predictability | Access January 2019 January 2019 2 Table of Contents Introduction 3 2018: Another Strong Year for Innovation and Advances 4 Novel Drugs 7 Impact of Novel Drug Approvals 9 Innovation: Frequent Use of Expedited Development and Review Pathways 18 Predictability: Meeting PDUFA Goals 20 Access: First Cycle Approval and Approvals Compared to Other Countries 21 New and Expanded Uses of Already FDA-Approved Drugs 22 New Uses 22 New Populations 25 Additional Approvals 26 Biosimilars 26 New Formulations and Other Notable Approvals 28 New Dosage Forms 30 Conclusion 31 Appendix A: Drug Designation Summary 32 Appendix B: Novel Drug Designation Summary 34 Advancing Health Through Innovation 3 Introduction Welcome to the FDA’s Center for Drug Evaluation and Research’s (CDER) annual report, Advancing Health Through Innovation: New Drug Ther

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